MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE-N AUTOGUARD; PERIPHERAL IV CATHETERS

Catalog Number	381411
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Unspecified Skin and Subcutaneous Tissue Problem (4927)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G.4.K201075; k251654 h.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.Attempts to clarify adverse patient outcome were unsuccessful.Customer did not respond.
Event or Problem Description
It was reported that the needle hub had a sharpness."customer placed 24 x 0.75 pivc in xxx patient - correct process and procedure was followed.Customer mentioned that there was a pressure wound from bd pivc as there was a sharpness on the catheter hub.".
Additional Manufacturer Narrative
Our quality engineer inspected the samples submitted for evaluation.Your report that the 24g insyte autoguard iv catheter caused or contributed to the reported pressure wound could not be confirmed from the returned sample.The 24g insyte autoguard iv catheter was received with an extension set.A visual and microscopic examination of the returned sample revealed no damage or defects associated with the manufacturing process.A functional test of the iv catheter revealed no damage.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We appreciate you taking the time to bring this observation to our attention.We regret any inconveniences this incident may have caused you and your facility.
Event or Problem Description
No new information.

• Brand Name: INSYTE-N AUTOGUARD
• Common Device Name: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 25184569
• Report Number: 1710034-2026-00516
• Device Sequence Number: 10427704
• Product Code: FOZ
• UDI-Device Identifier: 00382903814114
• UDI-Public: (01)00382903814114(11)251007(17)280831(10)5280605
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.11
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 381411
• Device Lot Number: 5280605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown